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CTRI Number  CTRI/2025/10/096242 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 20/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Study the Effect of Topical Losartan Eye-drops in Patients with Corneal Opacity in Terms of Decrease in Corneal Opacity and Scarring and Improvement in Vision. 
Scientific Title of Study   Effect of Topical Losartan in Patients with Corneal Opacity: A Pilot Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lokesh Paras Mandlecha 
Designation  Junior Resident 
Affiliation  DR RP CENTER OF OPHTHALMIC SCIENCE AIIMS 
Address  DEPARTMENT OF OPHTHALMOLOGY, DR RP CENTRE OF OPHTHALMIC SCIENCE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES

South
DELHI
110029
India 
Phone  7620740078  
Fax    
Email  lokeshmandlecha2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR NOOPUR GUPTA 
Designation  Professor 
Affiliation  DR RP CENTRE OF OPHTHALMIC SCIENCE AIIMS 
Address  ROOM NUMBER 475 , 4th FLOOR ,CORNEA SERVICES,DEPARTMENT OF OPHTHALMOLOGY, DR RP CENTRE OF OPHTHALMIC SCIENCE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES

South
DELHI
110029
India 
Phone  01126593111  
Fax    
Email  noopurgupta@hotmail.com  
 
Details of Contact Person
Public Query  
Name  DR NOOPUR GUPTA 
Designation  Professor 
Affiliation  DR RP CENTRE OF OPHTHALMIC SCIENCE AIIMS 
Address  ROOM NUMBER 475 , 4th FLOOR ,CORNEA SERVICES,DEPARTMENT OF OPHTHALMOLOGY, DR RP CENTRE OF OPHTHALMIC SCIENCE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES

South
DELHI
110029
India 
Phone  01126593111  
Fax    
Email  noopurgupta@hotmail.com  
 
Source of Monetary or Material Support  
DR RP CENTRE OF OPHTHALMIC SCIENCE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES AUROBINDO MARG ANSARI NAGAR NEW DELHI 
 
Primary Sponsor  
Name  DR RP CENTRE FOR OPHTHALMIC SCIENCES 
Address  AIIMS NEW DELHI AUROBINDO MARG ANSARI NAGAR 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lokesh Paras Mandlecha  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI  CORNEA SERVICES, DEPARTMENT OF OPHTHALMOLOGY, DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES.
South
DELHI 		 7620740078

lokeshmandlecha2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H179||Unspecified corneal scar and opacity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  USE OF PLACEBO (CARBOXYMETHYLCELLULOSE 0.5% EYE DROPS) IN PATIENTS WITH CORNEAL OPACITIES  PLACEBO (CARBOXYMETHYLCELLULOSE 0.5% EYE DROPS) WILL BE PUT 6 TIMES A DAY BY PATIENTS WITH CORNEAL OPACITY 
Intervention  USE OF TOPICAL LOSARTAN 0.08% EYE DROPS IN PATIENTS WITH CORNEAL OPACITIES  TOPICAL LOSARTAN 0.08% EYE DROPS WILL BE PUT 6 TIMES A DAY BY PATIENTS WITH CORNEAL OPACITY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Consenting adults (age above 18 years) with corneal opacity due to Keratitis, Ocular Trauma, Trachoma  
 
ExclusionCriteria 
Details  1.Patients having active ulcer.
2.Patients having active inflammation.
3.Patients having active infection.
4.Patients not willing to participate.
5.Patients on systemic medication. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of intervention on corneal opacity and scarring in terms of
1.Area of opacity as seen on slit lamp biomicroscopy.
2.Depth of scarring as seen on AS-OCT.
3.Scheimpflug-based Corneal Densitometry values.
4.Improvement in visual acuity. 		 Baseline, 2 weeks, 4 weeks, 12 weeks and 16 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a Pilot study to see the effect of Topical Losartan 0.08% eye drops in patients with corneal opacities compared to placebo.
Both patients and investigator will be blinded and patients will be randomly receiving either Topical Losartan 0.08% or the placebo (E/D CMC 0.5%) via pharmacy controlled randomization.
Patients will be asked to administer the eye drops 6 times a day and will be followed up at 2 weeks, 4 weeks, 12 weeks, 16 weeks when the effect of intervention will be compared based on area of opacity as seen on slit lamp biomicroscopy, depth of scarring as seen on AS-OCT, scheimpflug-based Corneal Densitometry values, improvement in visual acuity.
 
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